HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
FDA 510(k) clearance K003337 · decided 2000-12-21
Clearance details
- K-number
- K003337
- Device name
- HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
- Applicant
- Weck Closure Systems
- Decision
- Substantially Equivalent
- Date received
- 2000-10-25
- Decision date
- 2000-12-21
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Research Triangle Park, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium large size, non-absorbable p recall (Z-1096-06) | Teleflex Medical | 2006-06-09 |
| Weck Hem-o-lok L Polymer Ligating Clips; Rx, sterile, large size, non-absorbable polymer l recall (Z-1097-06) | Teleflex Medical | 2006-06-09 |